News Article | February 15, 2017
IsoPlexis Corporation (IsoPlexis), a venture-capital funded life sciences company developing an innovative cellular response analysis platform to measure the proteomic function of individual cells in patients, today announced it was recently awarded a competitive Phase I Small Business Innovation Research (SBIR) grant from the National Cancer Institute of the National Institutes of Health to develop a multi-protein, single-cell analysis platform to facilitate personalized cancer immunotherapy response detection. The funds for this SBIR grant will be used by IsoPlexis to advance the commercialization of a cell capture and single-cell protein analysis technology, addressing a rapidly growing need in cancer immunotherapy. This technology will not only provide comprehensive single-cell information to address biological and biomedical questions in academic research, but also offers a solution for the biotech and pharmaceutical industry to monitor patient T-cell function in antibody-mediated T-cell immunotherapies. "We continue to see a need to understand differences in patient responses to immunotherapy, and we are excited to be in a position to address these challenges with our platform," says Sean Mackay, CEO of IsoPlexis. "This award will help IsoPlexis commercialize our single-cell response profiling technologies in immunotherapy, and provide an important new solution for developing better biomarkers to address a critical need." IsoPlexis works with pharmaceutical companies and academic labs to test the efficacy and safety of new therapies in various areas of immunology, oncology, and other emerging disease areas. "We look forward to developing a better understanding of the cellular cytokine and chemokine responses pre- and post-immunotherapy, specifically those from T-cells, to better understand their role in response to the therapy and disease progression," said Tim McConnell, Director of Innovations and Operations at IsoPlexis, and the primary investigator of the project. IsoPlexis’ single-cell barcode platform (SCBC) improves upon existing solutions by providing highly-multiplexed, functional, secreted protein readouts, at single-cell resolution, to advance detection of important drivers of immune system activity. About IsoPlexis: IsoPlexis is a life sciences company developing a cellular response analysis platform that identifies a wide range of patient immune responses at the single-cell level. Its platform can assess safety and efficacy of therapeutics and monitor disease progression, enabling improved therapeutic development, and informing physician decisions. IsoPlexis is headquartered in Branford, Connecticut. For additional information on IsoPlexis, visit http://www.isoplexis.com or email email@example.com.
IsoPlexis | Date: 2015-12-03
Embodiments disclose apparatus, methods and software for performing biological screening and analysis implemented using an instrument platform capable of detecting a wide variety of cell-based secretions, expressed proteins, and other cellular components. The platform may be configured for simultaneous multiplexed detection of a plurality biological components such that a large number of discrete samples may be individually sequestered and evaluated to detect or identify constituents from the samples in a highly parallelized and scalable manner.
IsoPlexis | Date: 2016-03-11
IsoPlexis | Date: 2016-03-11
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 181.99K | Year: 2015
DESCRIPTION provided by applicant The most promising immunotherapies against cancer rely upon modulating CD and various CD T cells to activate against cancers like melanoma lymphoma and leukemia However the ability for researchers to measure the secreted effector proteins per heterogeneous T cell which determine the cellular potency against the cancer is limited today This Phase SBIR feasibility project proposes advancing the commercialization of a cell capture and single cell protein analysis technology to address pharmaceutical researchers need to monitor patient T cell function and response to therapy The prototype IsoPlexis micro device aims to for the first time gather the large and necessary amounts of secreted protein data at the single immune cell level The IsoPlexis micro device prototype currently helps immunology researchers at Yale University and Memorial Sloan Kettering Cancer Center detect up to ten times more secreted proteins per heterogeneous immune cell versus the standard flow cytometer Pharmaceutical firms have envisioned using this device to detect mechanism of action at the single cell level as well as potentially detect patient differences in immune competency As referenced in our support letters immunotherapy leaders from Yale Cancer Center and California Institute of Technology are looking forward to using and participating in the development of our prototype device IsoPlexisandapos micro device has the potential to provide this necessary additional functional data to many researchers thus advancing immunotherapy research faster and at a lower cost relative to competitorandapos s expensive instrument technologies The IsoPlexis device is initially targeting the T cell analysis sub segment of a broader $ million market for secreted protein life science research and drug development tools Eventually we hope to pursue much larger scale diagnostic applications for measuring patient immune activity pre and post therapy This Phase project seeks to better determine the commercial feasibility of developing the IsoPlexis cell capture and protein analysis micro device for mass research use using the following specific aims Develop on chip cell enrichment technology to facilitate single cell multi protein analysis of specific T cel subsets Here we apply DNA encoded cell sorting to capture CD and CD for downstream analysis in our IsoPlexis micro device prototype Develop a fully packaged micro device to achieve automated operation and minimum commercial usability We plan to engineer our device overcome key impediments of cell isolation quality of quantitative detection and detection variability Additionally we will pursue a pilot test for Transition to Phase II in thi we will demonstrate minimum validity andamp utility through proof of concept comparator validation analysis of primary T cells Upon completion of these initial improvement goals in Phase II IsoPlexis expects to expand product development of our cell isolation and protein analysis micro device to provide it to the many researchers that could benefit from the tool and to further explore diagnostic applications PUBLIC HEALTH RELEVANCE The proposed Phase SBIR feasibility study is designed to address a rapidly growing need for a device that provides much more secreted protein data per single cell in analyzing T cell activity in cancer immunotherapy This IsoPlexis prototype device will not only provide researchers the ability to measure the many secreted effector proteins per T cell but also will provide upstream isolation of CD and CD cells on chip It also does so in a low cost hand held device especially relative to expensive single cell instruments available today Upon development enabled by this SBIR the IsoPlexis device aims to put its high content single cell isolation and analysis micro device in the hands of many researchers in the pharmaceutical biotechnology and academic research world furthering cancer immunotherapy development
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 160.29K | Year: 2016
Despite the demonstrated benefit of CD targeted CAR T immunotherapeutics two challenges remain to bringing the therapeutics to market The first key challenge is to reproducibly manufacture the therapy so that the cellsandapos cytokine mediated function acts in a predictably consistent fashion post manufacturing The second key challenge is to manage the cellandapos s adverse effect immuno toxicity namely cytokine release syndrome CRS of IL and other inflammatory cytokines while also ensuring efficacy against the CD target A more effective pre infusion quality control test to ensure consistent and safe functioning would be not only address these two critical challenges but help pharmaceutical firms satisfy FDA concerns in both of these areas Such a test would have deep impact on ensuring the pharmas help these therapies to market and in making sure that patients in need with incurable B cell malignancies have access to these revolutionary therapies A more reliable in vitro CAR T functional test would allow physicians to remove or modify the inconsistent or unsafe cell therapies prior to injection significantly reducing risk to the patient and improving odds of therapeutic success However the current leading pre infusion tests do not address the most important clinical requirements The first requirement of such a test is to evaluate the CAR functional cell cytokine activation in the single cell poly functional cell subsets a correlate of quality immune response and also monitor for adverse functional reactions amongst these cell subsets That requires up to non overlapping cytokines per cell A second requirement is to measure the cellsandapos true secretions in an ex vivo manner rather than fixing the cells and manipulating their true function IsoPlexisandapos microchip technology meets these two needs for the first time It measures the range of efficacy polyfunctional cytokine markers anti tumor stimulatory chemotactic while measuring the CRS related inflammatory and also regulatory cytokines from those subsets up to cytokines per cell It does so in an ex vivo platform that not only measures true cell secretion to CD target but can also interact with and respond to the target cell directly on device IsoPlexis plans to use its core technology and learning to create an in vitro assessment test to measure for consistent range of function for in CAR T cell therapies and to monitor for markers of safety and efficacy We propose to do the following specific aims Develop a panel and reproducible assay for measurement of CD CAR cells upon interaction with CD immobilized to ensure consistent function to CAR target Implement the assay above with transfected CAR T donor samples and demonstrate a clinically useful workflow With the Phase I award support we expect in the future to use it as a companion diagnostics tool to monitor the response of patients and ensure proper management of these personalized living drugs in every patient justifying the broad impact of the proposed microdevice in immune oncology Despite the demonstrated benefit of emerging cancer immunotherapeutics their adverse effect e g immunotoxicity is a major concern and could be potentially life threatening We propose to further develop and validate our single cell cytokine mapping device and use it as a working platform to quality check the T cells immune effector function immunotoxity during CAR T treatment along with our pharmaceutical and academic partners In the future we expect to use our device as a companion diagnostics tool to monitor the response of patients and ensure proper management of these personalized living drugs in every patient which has a broad impact in immuno oncology
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 164.03K | Year: 2016
DESCRIPTION provided by applicant ELISpot including its variant FLUOROSpot remains the mainstay to measure true secretion of single cells and to assess cellular function e g immunity in the pre clinical and clinical settings However because it measures only one or two proteins per single cell and provides minimal biological information it has limited utility for measuring cell biology and physiological functions at the systems level Because a subset of the cells capable of producing multiple cytokines up to called polyfunctional cells dominate the overall response but currently no commercial tools are available to quantify polyfunctional cells at the highly multiplexed level representing a major barrier in both academic research and pharmaceutical industry to accurately quantify cellular immune responses Thus it is necessary to develop a technology that can measure an array of proteins from single cells and will help address a host of important biological and biomedical questions ranging from immune cell function heterogeneity stem cell differentiation drug resistance angiogenesis to cell cell communication networks Also this technology is of urgent need in biotech and pharmaceutical industry To address these challenges this technology needs to meet all three of the following requirements i Single cell sensitivity ii High multiplicity and iii High content IsoPlexi has a prototype hand held technology that for the first time provides the ability to measure many up to secreted effector proteins at the single T cell level At the same time this device in its envisioned form will be far less costly than existing single cell instruments representing a significant market advantage for wide spread use in pre clinical and clinical uses When applied to but not limited in the immunotherapeutics space our technology has the capability to detect the broadest mechanism of action at the single immune cell level and quantify the effector function of activated T cell response including polyfunctionality at a broad cellular leve to detect both effective response and potential toxicity autoimmunity With Phase support IsoPlexis plans to conduct the initial industrial Randamp D to turn this academic technology to a commercial product We propose to develop a fully packaged single cell protein secretion assay device to meet minimum commercial usability and validity standards develop computational pipelines and a software suite for automated data quantification and informatics We expect to develop a user friendly hardware and a software suite for reliable single cell multiplex protein secretion profiling and rapid data analysis This technology can not only provide comprehensive single cell information to address the biological and biomedical questions in academic research but also offers a solution for biotech and pharmaceutical industry to evaluate drug treatment responses at the single cell level PUBLIC HEALTH RELEVANCE We propose to conduct the initial industrial Randamp D to turn our current academic single cell multiplex secretion profiling technology to a commercial product By developing a user friendly hardware and a software suite we expect to perform reliable single cell secretion protein assay and rapid data analysis which is suitable for pre clinical and clinial application This technology can not only provide comprehensive single cell information to address the biological and biomedical questions in academic research but also offers a solution for biotech and pharmaceutical industry to evaluate drug treatment responses at the single cell level
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 164.02K | Year: 2016
DESCRIPTION provided by applicant Alzheimerandapos s disease AD is one of the most common neurodegenerative diseases that lead to detrimental outcomes such as progressive memory deficit and cognitive impairment Although it is expected that the prevalence of AD will double over the next years currently no widely accepted molecular biomarkers for early detection or non invasive monitoring of AD There has been increasing evidence that immune responses and brain inflammation are involved in the pathogenesis of neurodegenerative disorders in the central nervous system CNS The immune cells participating in the inflammatory response in the deep brain often get into cerebrospinal fluid CSF so called the andquot circulatoryandquot system of CNS and these cells carry the information about deep brain inflammatory pathology On the other hand while the blood brain barrier BBB restricts the entry of immune cells into the CNS a small number of immune cells can traverse into the CNS during pathophysiological states to participate in immune surveillance Excessive migration or abnormal functioning of these immune cells contribute to the development of neurodegenerative pathology It has been hypothesized that these trafficking leukocytes in CSF are potential cell markers to detect and measure inflammatory neurodegenerative disease However it remains challenging due to i the paucity of trafficking leukocytes cell microliter and the high degree of cellular heterogeneity with diverse immune effector functions proteins secreted by cells up to IsoPlexis has a prototype hand held technology that for the first time provides the ability to measure many up to of these key effector proteins at the single cell level At the same time this device in its envisioned form requires much less amount of cell input representing a major advantage over the existing single cell instruments e g flow cytometer for the specific application toward the analysis of rare trafficking leukocytes It will also be far less costly tha existing single cell instruments representing a significant market advantage Thus we plans to develop a fully integrated system that incorporates the enrichment of trafficking leukocytes using nanorough surfaces and single cell effector protein analysis on the same microdevice to truly enable the opportunity for wide spread use of trafficking leukocytes as the biomarker for early stage diagnosis and monitoring of inflammatory neurodegenerative diseases specifically AD To reach this goal we propose Incorporating a cell capture module in the IsoPlexis microdevice to perform on chip separation of low abundance leukocytes followed by highly multiplexed immune function analysis Develop an integrated carrier device to perform reliable operation of the integrated microchip for measuring rare trafficking leukocytes from CSF We expect to develop a unique and minimally invasive approach to quantitatively measure inflammatory conditions in deep brain for early diagnosis and therapeutic monitoring of AD using CSF This approach will also have broad impact on preclinical or clinical uses for routine screening or monitoring of inflammatory neurodegenerative diseases PUBLIC HEALTH RELEVANCE We propose to develop a fully integrated system that incorporates the enrichment of trafficking leukocytes from cerebrospinal fluid CSF using nanorough surfaces and single cell effector protein analysis on the same microdevice to truly enable the opportunity for wide spread use of trafficking leukocytes as the biomarker for early stage diagnosis and monitoring of inflammatory neurodegenerative diseases specifically Alzheimerandapos s disease This unique approach is minimally invasive and will have broad impact and unique value for preclinical or clinical uses for routine screening or monitoring of inflammatory neurodegenerative diseases
IsoPlexis | Date: 2017-01-20